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1.  Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study 
Background
Identification of prognostic factors for persistent pain and disability are important for better understanding of the clinical course of chronic unilateral lumbar radiculopathy and to assist clinical decision-making. There is a lack of scientific evidence concerning prognostic factors. The aim of this study was to identify clinically relevant predictors for outcome at 52 weeks.
Methods
116 patients were included in a sham controlled clinical trial on epidural injection of glucocorticoids in patients with chronic unilateral lumbar radiculopathy. Success at follow-up was ≤17.5 for visual analogue scale (VAS) leg pain, ≤22.5 for VAS back pain and ≤20 for Oswestry Disability Index (ODI). Fifteen clinically relevant variables included demographic, psychosocial, clinical and radiological data and were analysed using a logistic multivariable regression analysis.
Results
At follow-up, 75 (64.7%) patients had reached a successful outcome with an ODI score ≤20, 54 (46.6%) with a VAS leg pain score ≤17.5, and 47 (40.5%) with a VAS back pain score ≤22.5.
Lower age (OR 0.94 (CI 0.89–0.99) for each year decrease in age) and FABQ Work ≥34 (OR 0.16 (CI 0.04-0.61)) were independent variables predicting a successful outcome on the ODI.
Higher education (OR 5.77 (CI 1.46–22.87)) and working full-time (OR 2.70 (CI 1.02–7.18)) were statistically significant (P <0.05) independent predictors for successful outcome (VAS score ≤17.5) on the measure of leg pain. Lower age predicted success on ODI (OR 0.94 (95% CI 0.89 to 0.99) for each year) and less back pain (OR 0.94 (0.90 to 0.99)), while higher education (OR 5.77 (1.46 to 22.87)), working full-time (OR 2.70 (1.02 to 7.18)) and muscle weakness at baseline (OR 4.11 (1.24 to 13.61) predicted less leg pain, and reflex impairment at baseline predicted the contrary (OR 0.39 (0.15 to 0.97)).
Conclusions
Lower age, higher education, working full-time and low fear avoidance beliefs each predict a better outcome of chronic unilateral lumbar radiculopathy. Specifically, lower age and low fear avoidance predict a better functional outcome and less back pain, while higher education and working full-time predict less leg pain. These results should be validated in further studies before being used to inform patients.
Trial registration
Current Controlled Trials ISRCTN12574253. Registered 18 May 2005.
doi:10.1186/s12891-015-0474-9
PMCID: PMC4326298
Chronic unilateral lumbar radiculopathy; Lumbar nerve root impingement; Outcome prediction; Radiculopathy; Sciatica
2.  Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial 
Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome.
Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures.
Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years.
Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
doi:10.7150/ijms.4672
PMCID: PMC3461763  PMID: 23028241
Chronic low back pain; post lumbar surgery syndrome; recurrent disc herniation; epidural fibrosis; spinal stenosis; caudal epidural steroid injections.
3.  COMPARABLE EFFECTIVENESS OF CAUDAL VS. TRANS-FORAMINAL EPIDURAL STEROID INJECTIONS 
Study Design: Retrospective case-control study.
Objective: To compare the effectiveness between caudal and trans-foraminal epidural steroid injections for the treatment of primary lumbar radiculopathy.
Summary of Background Data: Spinal injections with steroids play an important role in non-operative care of lumbar radiculopathy. The trans-foraminal epidural steroid injection (TESI) theoretically has a higher success rate based on targeted delivery to the symptomatic nerve root. To our knowledge, these results have not been compared with other techniques of epidural steroid injection.
Methods: 93 patients diagnosed with primary lumbar radiculopathy of L4, L5, or SI were recruited for this study: 39 received caudal epidural steroid injections (ESI) and 54 received trans-foraminal epidural steroid injections (TESI). Outcomes scores included the SF-36, Oswestry disability index (ODI) and pain visual analogue scale (VAS), and were recorded at baseline, post-treatment (<6 months), long-term (>1 year). The average follow-up was 2 years, and 16 patients were lost to follow-up. The endpoint “surgical intervention” was a patient-driven decision, and considered failure of treatment. Intent-to-treat analysis, and comparisons included t-test, Chi-square, and Wilcoxon rank-sum test.
Results: Baseline demographics and outcomes scores were comparable for both treatment groups (ESI vs. TESI): (SF-36 PCS (32.3 ± 7.5 vs. 29.5 ± 8.9 respectively; p = 0.173), MCS (41.2 ± 12.7 vs. 41.1 ± 10.9, respectively; p = 0.971), and VAS (7.4 ±2.1 vs. 7.9 ± 1.2, respectively; p = 0.228)). Surgery was indicated for failure of treatment at a similar rate for both groups (41.0% vs. 44.4%, p=0.743). Symptom improvement was comparable between both treatment groups (ESI vs. TESI): SF-36 PCS improved to 42.0±11.8 and 37.7±12.3, respectively; p=0.49; ODI improved from 50.0±21.2 to 15.6±17.9and from 62.1±17.9 to 26.1±20.3, respectively (p=0.407).
Conclusions: The effectiveness of TESI is comparable to that of ESI (approximately 60%) for the treatment of primary lumbar radiculopathy. The increased complexity of TESI is not justified for primary cases, and may have a more specific role in recurrent disease or for diagnostic purposes.
PMCID: PMC2723700  PMID: 19742093
4.  Assessment of Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Low Back Pain Secondary to Lumbar Central Spinal Canal Stenosis 
Background: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied.
Study Design: A prospective evaluation.
Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Objective: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis.
Methods: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter.
Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores.
Results: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73.
Limitations: The lack of a control group and a prospective design.
Conclusions: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.
doi:10.7150/ijms.5303
PMCID: PMC3534877  PMID: 23289005
Central spinal stenosis; percutaneous adhesiolysis; steroids; local anesthetics; hypertonic sodium chloride solution
5.  The flow patterns of caudal epidural in upper lumbar spinal pathology 
European Spine Journal  2010;20(5):804-807.
Epidural steroid injections are an important therapeutic modality employed by spinal surgeons in the treatment of patients with chronic low back pain with or without lumbar radiculopathy. The caudal epidural is a commonly used and well-established technique; however, little is known about the segmental level of pathology that may be addressed by this intervention. This prospective study of over 50 patients aimed to examine the spreading pattern of this technique using epidurography. The effect of variation in Trendelenburg tilt and the eradication of lumbar lordosis on the cephalic distribution of the injectate were investigated. 52 patients with low back pain and radiculopathy underwent caudal epidural. All had 20 ml volume injected, comprised of 5 ml contrast (Ultravist™ Schering) 2 ml Triamcinolone (Adcortyl™ Squibb) and 13 ml local anaesthetic (1% lignocaine). Patients were randomised to either 0° or 30° of Trendelenburg tilt, as referenced from the lumbar spine. Patients were further randomised to presence or absence of lumbar lordosis, which was eradicated using a flexion device placed beneath the prone patient. A lateral image of each sacrum was obtained, to identify variations in sacral geometry particularly resistant to cephalic spread of injectate. The highest segment reached on fluoroscopy was recorded post injection. Fifty-two patients with a mean age of 50 years underwent caudal epidural. Thirty-one were in 0° head tilt, with 21 in 30° of head tilt. In each of these groups, 50% had their lumbar lordosis flattened prior to caudal injection. The median segmental level reached was L3, with a range from T9 to L5. Eradication of lumbar lordosis did not significantly alter cephalic spread of injectate. There was a trend for 30° tilt to extend the upper level reached by caudal injection (p = 0.08). There were no adverse events in this series. Caudal epidural is a reliable and relatively safe procedure for the treatment of low back pain. Pathology at L3/4 and L4/5 and L5/S1 can be approached by this technique. Although in selected cases thoracic and high lumbar levels can be reached, this is variable. If pathology at levels above L3 needs to be addressed, we propose a 30° head tilt may improve cephalic drug delivery. The caudal route is best reserved for pathology below L3.
doi:10.1007/s00586-010-1613-5
PMCID: PMC3082677  PMID: 21113636
Caudal epidural; Lumbar spine
6.  Transforaminal injection of corticosteroids for lumbar radiculopathy: systematic review and meta-analysis 
European Spine Journal  2011;21(2):214-219.
Background
Transforaminal epidural injection of steroids is used to treat lumbar radicular pain. However, there are only a few well-designed randomized, controlled studies on the effectiveness of steroid injection.
Study design
Hence, this study aims to assess the effectiveness of steroid injection to treat lumbar radicular pain using a meta-analysis of transforaminal epidural injection therapy for low back and lumbar radicular pain. The comparison was based on the mean difference in the Visual Analogue Score (VAS) and Oswestry Disability Index (ODI) from baseline to the specified followed up.
Methods
The available literature of lumbar transforaminal epidural injections in managing low back and radicular pain was reviewed. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to 2009, and manual searches of the bibliographies of known primary and review articles. Finally, the search included the Current Controlled Trials Register and the Cochrane Database of Controlled Trials.
Results
The initial search identified 126 papers. After screening, five randomised controlled trials (RCTs) were studied for analysis and only three of these had followed-up patients systematically with pain and disability outcome scores to 3 months and of these, only one had follow up to 12 months. A total of 187 patients (‘treatment group’ receiving local anaesthetic/steroid injection) were compared with 181 patients (‘control’ group, receiving local anaesthetic only or saline injection). Improvement in pain (standardised mean difference in VAS 0.2 in favour of ‘treatment’; 95%CI: −0.41 to 0.00, p = 0.05, I squared 0%) but not disability (standardised mean difference in ODI 0; 95%CI: −0.21 to 0.20, p = 0.99, I squared 0%) was observed between ‘treatment’ and ‘control’ groups; these differences were not significant. Additionally, the one study following patients to 12 months did not find any significant difference in VAS and ODI between treatment and control groups.
Conclusion
The current meta-analysis shows that transforaminal epidural steroid injections, when appropriately performed, should result in an improvement in pain, but not disability. The three RCTs that followed patients to 3 months (and the single study to 12 months) have found no benefit by the addition of steroids. The limitations of this study include the paucity of the available literature.
doi:10.1007/s00586-011-2008-y
PMCID: PMC3265602  PMID: 21892774
Transforaminal epidural steroids; Radiculopathy; Sciatica; Steroids; Local anaesthetic
7.  Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain 
Journal of Pain Research  2012;5:301-311.
Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.
doi:10.2147/JPR.S32699
PMCID: PMC3442746  PMID: 23055773
lumbar disc herniation; axial or discogenic pain; lumbar interlaminar epidural injections; local anesthetic; steroids; controlled comparative local anesthetic blocks; NCT00681447
8.  Analysis of Efficacy Differences between Caudal and Lumbar Interlaminar Epidural Injections in Chronic Lumbar Axial Discogenic Pain: Local Anesthetic Alone vs. Local Combined with Steroids 
Study Design: Comparative assessment of randomized controlled trials of caudal and lumbar interlaminar epidural injections in chronic lumbar discogenic pain.
Objective: To assess the comparative efficacy of caudal and lumbar interlaminar approaches of epidural injections in managing axial or discogenic low back pain.
Summary of Background Data: Epidural injections are commonly performed utilizing either a caudal or lumbar interlaminar approach to treat chronic lumbar axial or discogenic pain, which is pain exclusive of that associated with a herniated intervertebral disc, or that is due to degeneration of the zygapophyseal joints, or due to dysfunction of the sacroiliac joints, respectively. The literature on the efficacy of epidural injections in managing chronic axial lumbar pain of presumed discogenic origin is limited.
Methods: The present analysis is based on 2 randomized controlled trials of chronic axial low back pain not caused by disc herniation, radiculitis, or facet joint pain, utilizing either a caudal or lumbar interlaminar approach, with a total of 240 patients studied, and a 24-month follow-up. Patients were assigned to receive either local anesthetic only or local anesthetic with a steroid in each 60 patient group.
Results: The primary outcome measure was significant improvement, defined as pain relief and functional status improvement of at least 50% from baseline, which was reported at 24-month follow-ups in 72% who received local anesthetic only with a lumbar interlaminar approach and 54% who received local anesthetic only with a caudal approach. In patients receiving local anesthetic with a steroid, the response rate was 67% for those who had a lumbar interlaminar approach and 68% for those who had a caudal approach at 12 months. The response was significantly better in the lumbar interlaminar group who received local anesthetic only, 77% versus 56% at 12 months and 72% versus 54% at 24 months.
Conclusion: This assessment shows that in patients with axial or discogenic pain in the lumbar spine after excluding facet joint and SI Joint pain, epidural injections of local anesthetic by the caudal or lumbar interlaminar approach may be effective in managing chronic low back pain with a potential superiority for a lumbar interlaminar approach over a caudal approach.
doi:10.7150/ijms.10870
PMCID: PMC4323359
Chronic low back pain; axial low back pain; lumbar discogenic pain; caudal epidural injections; lumbar interlaminar epidural injections.
9.  Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis, or facet joint pain 
Journal of Pain Research  2012;5:381-390.
Background
Chronic low back pain without disc herniation is common. Various modalities of treatments are utilized in managing this condition, including epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections.
Methods
A randomized, double-blind, actively controlled trial was conducted. The objective was to evaluate the ability to assess the effectiveness of caudal epidural injections of local anesthetic with or without steroids for managing chronic low back pain not caused by disc herniation, radiculitis, facet joints, or sacroiliac joints. A total of 120 patients were randomized to two groups; one group did not receive steroids (group 1) and the other group did (group 2). There were 60 patients in each group. The primary outcome measure was at least 50% improvement in Numeric Rating Scale and Oswestry Disability Index. Secondary outcome measures were employment status and opioid intake. These measures were assessed at 3, 6, 12, 18, and 24 months after treatment.
Results
Significant pain relief and functional status improvement (primary outcome) defined as a 50% or more reduction in scores from baseline, were observed in 54% of patients in group 1 and 60% of patients in group 2 at 24 months. In contrast, 84% of patients in group 1 and 73% in group 2 saw significant pain relief and functional status improvement in the successful groups at 24 months.
Conclusion
Caudal epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.
doi:10.2147/JPR.S35924
PMCID: PMC3474158  PMID: 23091395
chronic axial low back pain; discogenic pain; disc herniation; caudal epidural injections
10.  Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults 
Background
Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.
Methods
We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.
Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.
Discussion
This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.
Trial Registration
Clinicaltrials.gov NCT01238536
doi:10.1186/1471-2474-13-48
PMCID: PMC3349603  PMID: 22458343
11.  Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial 
Journal of Pain Research  2012;5:597-608.
Background
The literature is replete with evaluations of failed surgery, illustrating a 9.5%–25% reoperation rate. Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, recurrent disc herniation, sacroiliac joint pain, and facet joint pain among other causes.
Methods
Patients (n = 120) were randomly assigned to two groups with a 2-year follow-up. Group I (control group, n = 60) received caudal epidural injections with catheterization up to S3 with local anesthetic (lidocaine 2%, 5 mL), nonparticulate betamethasone (6 mg, 1 mL), and 6 mL of 0.9% sodium chloride solution. Group II (intervention group, n = 60) received percutaneous adhesiolysis of the targeted area, with targeted delivery of lidocaine 2% (5 mL), 10% hypertonic sodium chloride solution (6 mL), and nonparticulate betamethasone (6 mg). The multiple outcome measures included the Numeric Rating Scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as 50% improvement in pain and Oswestry Disability Index scores.
Results
Significant improvement with at least 50% relief with pain and improvement in functional status was illustrated in 82% of patients at the 2-year follow-up in the intervention group compared to 5% in the control group receiving caudal epidural injections. The average number of procedures over a period of 2 years in Group II was 6.4 ± 2.35 with overall total relief of approximately 78 weeks out of 104 weeks.
Conclusion
The results of this study show significant improvement in 82% of patients over a period of 2 years with an average of six to seven procedures of 1-day percutaneous adhesiolysis in patients with failed back surgery syndrome.
doi:10.2147/JPR.S38999
PMCID: PMC3533727  PMID: 23293536
epidural adhesions; epidural steroid injections; epidural fibrosis
12.  Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial 
Trials  2014;15:105.
Background
Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis.
Methods/Design
The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation).
Discussion
This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis.
Trial registration
This trial is registered with the US National Institutes of Health Clinical Trials registry: NCT01909284.
doi:10.1186/1745-6215-15-105
PMCID: PMC4006524  PMID: 24693959
Acupuncture; Interlaminar epidural steroid injection; Spondylolisthesis
13.  A prospective randomized, double-blind, controlled clinical trial comparing epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus 
Objective:
To compare the efficacy of up to 3 epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus.
Materials and Methods:
In a randomized, double-blind controlled clinical trial, we administered up to 3 epidural injections of either 80 mg (2 mL) of methylprednisolone acetate and 1 mg (1 mL) of butorphanol diluted with 7 mL of isotonic saline or 80 mg (2 mL) of methylprednisolone acetate diluted with 8 mL of isotonic saline by a lumbar interlaminar approach under fluoroscopic guidance to 120 patients (60 patients in each group) with sciatica due to a herniated nucleus pulposus lasting for 4 weeks to 1 year. All patients had scores higher than 30 mm on visual analog scale (VAS). Information on the use of paracetamol, intensity of pain on a VAS ranging from 0 (no pain) to 100 mm (worst pain possible), Schober's test (cm), Straight Leg Raising test, neurologic examination assessing sensory deficits, motor deficits and reflex changes, and Oswestry Low Back Pain Disability Questionnaire were evaluated at 3 weeks, 6 weeks, and 3 months after the first injection.
Results:
There were no significant differences between the 2 groups with regard to baseline characteristics, withdrawals, and complication rate. Three weeks, 6 weeks, and 3 months after the first injection, all the outcome measures in the butorphanol plus corticosteroid group were significantly different from that of the corticosteroid group.
Conclusions:
Epidural butorphanol plus corticosteroid injections, as compared with corticosteroid alone injections, offered marked improvement in pain, reflex, motor and sensory deficits, and functional status and reduced the need for analgesics.
Level of Evidence:
Therapeutic Level I.
doi:10.4103/2229-3485.92302
PMCID: PMC3275988  PMID: 22347697
Butorphanol; epidural; sciatica
14.  Low back pain (acute) 
Clinical Evidence  2008;2008:1102.
Introduction
Low back pain (LBP) affects about 70% of people in resource-rich countries at some point. Acute low back pain is usually perceived as self-limiting; however, one year later, as many as 33% of people still have moderate-intensity pain and 15% have severe pain. It has a high recurrence rate; 75% of those with a first episode have a recurrence. Although acute episodes may resolve completely, they may also increase in severity and duration over time.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments for low back pain? What are the effects of local injections for low back pain? What are the effects of non-drug treatments for low back pain? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 34 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, advice to stay active, analgesics (paracetamol, opioids), back exercises, back schools, bed rest, behavioural therapy, electromyographic biofeedback, epidural corticosteroid injections, lumbar supports, massage, multidisciplinary treatment programmes, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), spinal manipulation (in the short term), temperature treatments (short wave diathermy, ultrasound, ice, heat), traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Low back pain is pain, muscle tension, or stiffness, localised below the costal margin and above the inferior gluteal folds, with or without referred or radicular leg pain (sciatica), and is defined as acute when pain persists for less than 12 weeks. Low back pain affects about 70% of people in resource-rich countries at some point.Acute low back pain is usually self-limiting, although 2-7% develop chronic pain. Acute low back pain has a high recurrence rate with less-painful symptoms recurring in 50-80% of people within a year; one year later, as high as 33% still experience moderate-intensity pain and 15% experience severe pain.
NSAIDs have been shown to effectively improve symptoms compared with placebo. However, their use is associated with gastrointestinal adverse effects. Muscle relaxants may also reduce pain and improve overall clinical assessment, but are associated with some severe adverse effects including drowsiness, dizziness, and nausea.The studies examining the effects of analgesics such as paracetamol or opioids were generally too small to detect any clinically important differences.
We found no studies examining the effectiveness of epidural injections of corticosteroids in treating people with acute low back pain.
With regard to non-drug treatments, advice to stay active (be it as a single treatment or in combination with other interventions such as back schools, a graded activity programme, or behavioural counselling) seems the most effective. Spinal manipulation (in the short term) also seems to reduce pain, but not functional outcomes, compared with sham treatments.We found insufficient evidence to judge the effectiveness of acupuncture, back schools, behavioural therapy, massage, multidisciplinary treatment programmes (for either acute or subacute low back pain), ortemperature treatments in treating people with acute low back pain.We found no evidence examining the effectiveness of electromyographic biofeedback, lumbar supports, traction, or TENS in the treatment of acute low back pain. Back exercises do not seem to increase recovery time compared with no treatment, although there is considerable heterogeneity among studies with regard to the definition of back exercise. There is also disparity among studies in the definition of generic and specific back exercise. Bed rest does not improve symptoms any more effectively than other treatments, but does produce a number of adverse effects including joint stiffness, muscle wasting, loss of bone mineral density, pressure sores, and venous thromboembolism.
PMCID: PMC2907975  PMID: 19445792
15.  Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial 
Study Design: A randomized, double-blind, active-controlled trial.
Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain.
Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain.
Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone.
The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight.
Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up.
Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.
doi:10.7150/ijms.8069
PMCID: PMC3936024  PMID: 24578607
Chronic neck pain; cervical discogenic pain; cervical axial pain; cervical disc herniation; cervical epidural injections; epidural steroids; local anesthetics.
16.  Lumbar epidural perineural injection: a new technique 
European Spine Journal  1997;6(5):357-361.
Two controlled studies for a new epidural, perineural, singleshot, selective nerve root injection with a double-needle approach to the anterior epidural space of the lumbar spinal canal are presented. The results were analysed to determine the effectiveness of the new epidural perineural injection technique. The trial comprised two controlled studies on 182 patients. One study compared prospectively randomized results of patients with lumbar radicular syndromes who received epidural perineural injections (n = 47), conventional posterior epidural injections (n = 40) and, as a control group, paravertebral local anaesthetic (n = 46). A second, prospective, double-blind study compared the effect of epidural perineural injections with triamcinolone (n = 24) and pure saline (n = 25). Epidural perineural injections were more effective than conventional posterior epidural injections. Both epidural groups had better results than the paravertebral local injection group. Epidural perineural injections with steroids (10 mg triamcinolone) were more effective than saline alone. A systemic steroid effect was excluded by additional intramuscular steroid injections in the saline group. There were no severe complications or side effects in any of the three groups. The studies concluded that single-shot epidural perineural injection is effective in the treatment of lumbar radicular pain. It is a “one drop only” therapy to the source of pain.
doi:10.1007/BF01142687
PMCID: PMC3454603  PMID: 9391811
Epidural perineural injection; Local injection therapy; Lumbar radicular syndrome; Conservative treatment
17.  Neck pain 
Clinical Evidence  2008;2008:1103.
Introduction
Non-specific neck pain has a postural or mechanical basis and affects about two thirds of people at some stage, especially in middle age. Acute neck pain resolves within days or weeks, but may become chronic in about 10% of people. Whiplash injuries follow sudden acceleration–deceleration of the neck, such as in road traffic or sporting accidents. Up to 40% of people continue to report symptoms 15 years after the accident, although this varies between countries.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for people with non-specific neck pain without severe neurological deficit? What are the effects of treatments for acute whiplash injury? What are the effects of treatments for chronic whiplash injury? What are the effects of treatments for neck pain with radiculopathy? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2007 (BMJ Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 91 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of the evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, biofeedback, drug treatments (analgesics, antidepressants, epidural steroid injections, muscle relaxants, non-steroidal anti-inflammatory drugs [NSAIDs]), early mobilisation, early return to normal activity, exercise, heat or cold, manipulation (alone or plus exercise), mobilisation, multimodal treatment, patient education, percutaneous radiofrequency neurotomy, physical treatments, postural techniques (yoga, pilates, Alexander technique), pulsed electromagnetic field (PEMF) treatment, soft collars and special pillows, spray and stretch, surgery, traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Non-specific neck pain has a postural or mechanical basis, and affects about two thirds of people at some stage, especially in middle age. Acute neck pain resolves within days or weeks, but becomes chronic in about 10% of people.Whiplash injuries follow sudden acceleration–deceleration of the neck, such as in road traffic or sporting accidents. Up to 40% of people continue to report symptoms 15 years after the accident.
The evidence about the effects of individual interventions for neck pain is often contradictory because of poor quality RCTs, the tendency for interventions to be given in combination, and for RCTs to be conducted in diverse groups. This lack of consistency in study design makes it difficult to isolate which intervention may be of use in which type of neck pain.
Stretching and strengthening exercise reduces chronic neck pain compared with usual care, either alone or in combination with manipulation, mobilisation, or infrared. Manipulation and mobilisation may reduce chronic pain more than usual care or less-active exercise. They seem likely to be as effective as each other or as exercise, and more effective than pulsed electromagnetic field (PEMF) treatment, or than heat treatment. Acupuncture may be more effective than some types of sham or inactive treatment at improving pain relief and quality of life at the end of treatment or in the short term.
Analgesics, NSAIDs, antidepressants, and muscle relaxants are widely used to treat chronic neck pain, but we don't know whether they are effective.
We don't know whether traction, PEMF treatment, TENS, heat or cold, biofeedback, spray and stretch, multimodal treatment, patient education, soft collars, or special pillows are better or worse than other treatments at reducing chronic neck pain.
Early mobilisation may reduce pain in people with acute whiplash injury compared with immobilisation or rest with a collar. We don't know whether exercise, early return tonormal activity, PEMF treatment, multimodal treatment, or drug treatment can reduce pain in people with acute whiplash injury.
We don't know whether percutaneous radiofrequency neurotomy, multimodal treatment, or physical treatment reduce pain in people with chronic whiplash injury.
We don't know whether surgery, analgesics, NSAIDs, muscle relaxants, or cervical epidural steroid injections reduce pain in people with neck pain plus radiculopathy.
PMCID: PMC2907992  PMID: 19445809
18.  Arachnoiditis Following Caudal Epidural Injections for the Lumbo-Sacral Radicular Pain 
Asian Spine Journal  2013;7(4):355-358.
Caudal epidural steroid injection is a very common intervention in treatment of low back pain and sciatica symptoms. Although extensively used, it is not devoid of complications. A few reports of chemical and infective arachnoiditis exist following lumbar epidural anaesthesia, but none following a caudal epidural steroid injection.We report a case of arachnoiditis following caudal epidural steroid injections for lumbar radiculopathy. The patient presented with contralateral sciatica, worsening low back pain and urinary retention few days following the injection, followed by worsening motor functions in L4/L5/S1 myotomes with resultant dense foot drop. Gadolinium-enhanced magnetic resonance imaging suggested infective arachnoiditis with diffuse enhancement and clumping of the nerve roots within the lumbar and sacral thecal sac. As the number of injections in the management of back pain and lumbo-sacral radicular pain is increasing annually, it is imperative to have a thorough understanding of this potentially dangerous complication and educate the patients appropriately.
doi:10.4184/asj.2013.7.4.355
PMCID: PMC3863664  PMID: 24353855
Caudal; Epidural; Low back pain; Sciatica; Arachnoiditis
19.  Cephalic spreading levels after volumetric caudal epidural injections in chronic low back pain. 
Journal of Korean Medical Science  2001;16(2):193-197.
The volumetric caudal epidural steroid injection has been advocated to facilitate the delivery of medications to the lesion site. This study was aimed to examine the actual spreading patterns of this technique, using epidurogram. A total of 32 patients with chronic low back pain accompanied by radiculopathy of various causes (degenerative spondylosis, herniated nucleus pulposus, spondylolisthesis, and spinal stenosis) were included. The volumetric caudal epidural injection of the 10 mL mixture of contrast medium 5 mL, 0.5% bupivacaine 1 mL, triamcinolone 1.5 mL (60 mg) and normal saline 25 mL was performed. Immediately after the cessation of the first spread, the subsequent solution of another 10 mL of contrast medium 5 mL, 0.5% bupivacaine 1 mL and normal saline 4 mL was injected. This procedure was repeated serially until the total volume to be 50 mL. Continuous fluoroscopic imaging was obtained after each injection. Average time taken to complete the study was 37 sec per every 10 mL. The spreading levels of the mixture were distributed mainly at mid to lower lumbar area in the majority of the patients. During the subsequent injections, the levels were not changed significantly. This was thought to be due to the minimal resistance in cephalad direction, anatomic variations and Starling effect of epidural space.
PMCID: PMC3054722  PMID: 11306746
20.  Is Immediate Imaging Important in Managing Low Back Pain? 
Journal of Athletic Training  2011;46(1):99-102.
Abstract
Reference:
Chou R, Fu R, Carrino JA, Deyo RA. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009;373(9662):463–472.
Clinical Questions:
In patients with low back pain (LBP) who do not have indications of a serious underlying condition, does routine, immediate lumbar imaging result in improved patient outcomes when compared with clinical care without immediate imaging?
Data Sources:
Studies were identified by searching MEDLINE (1966 through first week of August 2008) and the Cochrane Central Register of Controlled Trials (third quarter of 2008). The reference lists of identified studies were manually reviewed for additional citations. The search terms spine, low-back pain, diagnostic imaging, and randomized controlled trials were used in both databases. The complete search strategy was made available as an online supplement.
Study Selection:
The search criteria were applied to the articles obtained from the electronic searches and the subsequent manual searches with no language restrictions. This systematic review and meta-analysis included randomized, controlled trials that compared immediate, routine lumbar imaging (or routine provision of imaging findings) with usual clinical care without immediate lumbar imaging (or not routinely providing results of imaging) for LBP without indications of serious underlying conditions.
Data Extraction:
Data extraction and assessment of study quality were well described. The trials assessed one or more of the following outcomes: pain, function, mental health, quality of life, patient satisfaction, and overall patient-reported improvement. Two reviewers independently appraised citations considered potentially relevant, with disagreements between reviewers resolved by consensus. Two independent reviewers abstracted data from the trials and assessed quality with modified Cochrane Back Review Group criteria. The criterion for blinding of patients and providers was excluded because of lack of applicability to imaging studies. In addition, the criterion of co-intervention similarity was excluded because a potential effect of different imaging strategies is to alter subsequent treatment decisions. As a result of excluding these criteria, quality ratings were based on the remaining 8 criteria. The authors resolved disagreements about quality ratings through discussion and consensus. Trials that met 4 or more of the 8 criteria were classified as higher quality, whereas those that met 3 or fewer of the 8 criteria were classified as lower quality. In addition, the authors categorized duration of symptoms as acute (<4 weeks), subacute (4–12 weeks), or chronic (>12 weeks). The investigators also contacted the study authors for additional data if included outcomes were not published or if median (rather than mean) outcomes were reported. Statistical analysis was conducted on the primary outcomes of improvement in pain or function. Secondary outcomes of improvement in mental health, quality of life, patient satisfaction, and overall improvement were also analyzed. Outcomes were categorized as short term (≤3 months), long term (>6 months to ≤1 year), or extended (>1 year). For continuous outcomes, standardized mean differences (SMDs) of interventions for change between baseline and follow-up measurements were calculated. In studies reporting the same pain (visual analog scale [VAS] or Short Form-36 bodily pain score) or function (Roland-Morris Disability Questionnaire [RDQ]) outcomes, weighted mean differences (WMDs) were calculated. In all analyses, lower pain and function scores indicated better outcomes. For quality-of-life and mental health outcomes, higher scores indicated improved outcomes. All statistical analyses were performed with Stata 10.0. For outcomes in which SMDs were calculated, values of 0.2 to 0.5 were considered small, 0.5 to 0.8 were considered moderate, and values greater than 0.8 were considered large. For WMDs, mean improvements of 5 to 10 points on a 100-point scale (or equivalent) were considered small, 10-point to 20-point changes were considered moderate, and changes greater than 20 points were considered large. For the RDQ, mean improvements of 1 to 2 points were termed small, and improvements of 2 to 5 points were termed moderate.
Main Results:
The total number of citations identified using the search criteria was 479 articles and abstracts. Of these, 466 were excluded because either they were not randomized trials or they did not use imaging strategies for LBP. At this step, 13 articles were retrieved for further analysis. This analysis resulted in 3 additional articles being excluded (1 was not a randomized trial and the other 2 compared 2 imaging techniques rather than immediate imaging versus no imaging). The final step resulted in the inclusion of 6 trials reported in 10 publications for the meta-analysis. In the studies meeting the inclusion criteria, 4 assessed lumbar radiography and 2 assessed magnetic resonance imaging (MRI) or computed tomography (CT) scans. In these 6 trials, 1804 patients were randomly assigned to the intervention group. The duration of patient follow-up ranged from 3 weeks to 2 years. In addition, 1 trial excluded patients with sciatica or other radiculopathy symptoms, whereas another did not report the proportion of patients with these symptoms. In the other 4 studies, the proportion of patients with sciatica or radiculopathy ranged from 24% to 44%. Of the included trials, 3 compared immediate lumbar radiography with usual clinical care without immediate radiography, and a fourth study compared immediate lumbar radiography and a brief educational intervention with lumbar radiography if no improvement was seen by 3 weeks. The final 2 studies assessed advanced imaging modalities. Specifically, one group compared immediate MRI or CT with usual clinical care without advanced imaging in patients with primarily chronic LBP (82% with LBP for >3 months) who were referred to a surgeon. In the other advanced imaging study, all patients with LBP for <3 weeks underwent MRI and were then randomized to routine notification of results or to notification of results only if clinically indicated. With respect to study quality, 5 trials met at least 4 of the 8 predetermined quality criteria, leading to a classification of higher quality. In addition, 5 trials were included in the primary meta-analysis on pain or function improvement at 1 or more follow-up periods. With regard to short-term and long-term improvements in pain, no differences were noted between routine, immediate lumbar imaging and usual clinical care without immediate imaging (Table 1). In studies using the VAS pain score, the WMD (0.62, 95% confidence interval [CI]  =  0.03, 1.21) at short-term follow-up slightly favored no immediate imaging. No differences in outcome were seen in studies using the Short Form-36 bodily pain score. No improvements in function at short-term or long-term follow-up were noted between imaging strategies. Specifically, short-term function measured with the RDQ in 3 studies showed a WMD of 0.48 points (95% CI  =  −1.39, 2.35) between imaging strategies, whereas long-term function in 3 studies, also measured with the RDQ, showed a WMD of 0.33 points (95% CI  =  −0.65, 1.32). One included trial reported pain outcomes at extended (2-year) follow-up and found no differences between imaging strategies for pain (Short Form-36 bodily pain or Aberdeen pain score), with SMDs of −2.7 (95% CI  =  −6.17, 0.79) and −1.6 (−4.04, 0.84), respectively. The outcomes between immediate imaging and usual clinical care without immediate imaging did not differ for short-term follow-up in those studies reporting quality of life (SMD  =  −0.10, 95% CI  =  −0.53, 0.34), mental health (SMD  =  0.12, 95% CI  =  −0.37, 0.62), or overall improvement (mean risk ratio  =  0.83, 95% CI  =  0.65, 1.06). In those studies reporting long-term follow-up periods, similar results can be seen for quality of life (SMD  =  −0.15, 95% CI  =  −0.33, 0.04) and mental health (SMD  =  0.01, 95% CI  =  −0.32, 0.34). In the study reporting extended follow-up, immediate imaging was not better in terms of improving quality of life (SMD  =  0.02, 95% CI  =  −0.02, 0.07) or mental health (SMD  =  −1.50, 95% CI  =  −4.09, 1.09) when compared with usual clinical care without immediate imaging. In the included studies, no cases of cancer, infection, cauda equina syndrome, or other serious diagnoses were reported in patients randomly assigned to either imaging strategy.
Conclusions:
Available evidence indicates that immediate, routine lumbar spine imaging in patients with LBP and without features indicating a serious underlying condition did not improve outcomes compared with usual clinical care without immediate imaging. Clinical care without immediate imaging seems to result in no increased odds of failure in identifying serious underlying conditions in patients without risk factors for these conditions. In addition to lacking clinical benefit, routine lumbar imaging is associated with radiation exposure (radiography and CT) and increased direct expenses for patients and may lead to unnecessary procedures. This evidence confirms that clinicians should refrain from routine, immediate lumbar imaging in primary care patients with nonspecific, acute or subacute LBP and no indications of underlying serious conditions. Specific consideration of patient expectations about the value of imaging was not addressed here; however, this aspect must be considered to avoid unnecessary imaging while also meeting patient expectations and increasing patient satisfaction.
doi:10.4085/1062-6050-46.1.99
PMCID: PMC3017496  PMID: 21214357
spine; assessment; outcomes
21.  Comparison of the caudal and lumbar approaches to the epidural space 
Annals of the Rheumatic Diseases  2000;59(11):879-882.
OBJECTIVES—To investigate the accuracy of placement of epidural injections using the lumbar and caudal approaches. To identify which factors, if any, predicted successful placement.
METHODS—200 consecutive patients referred to a pain clinic for an epidural injection of steroid were randomly allocated to one of two groups. Group L had a lumbar approach to the epidural space and group C a caudal approach to the epidural space. Both groups then had epidurography performed using Omnipaque and an image intensifier to determine the position of the needle.
RESULTS—Body mass index (BMI), grade of operator, and route of injection were predictors of a successful placement. 93% of lumbar and 64% of caudal epidural injections were correctly placed (p< 0.001). 97% of lumbar and 85% of caudal epidural injections clinically thought to be correctly placed were confirmed radiographically. For epidural injections where the clinical impression was "maybe", 91% of lumbar injections, but only 45% of caudal injections were correctly placed. Obesity was associated with a reduced chance of successful placement (odds ratio (OR) 0.34 (95% confidence interval (CI) 0.17 to 0.72) BMI >30 v BMI <30). A more senior grade of operator was associated with a reduced chance of successful placement (OR 0.16 (95% CI 0.03 to 0.89) consultant v other). However, small numbers may have accounted for the latter result.
CONCLUSIONS—The weight of the patient and intended approach need to be considered when deciding the method used to enter the epidural space. In the non-obese patient, lumbar epidural injections can be accurately placed without x ray screening, but caudal epidural injections, to be placed accurately, require x ray screening no matter what the weight of the patient.


doi:10.1136/ard.59.11.879
PMCID: PMC1753031  PMID: 11053065
22.  Low back pain (acute) 
Clinical Evidence  2011;2011:1102.
Introduction
Low back pain affects about 70% of people in resource-rich countries at some point in their lives. Acute low back pain can be self-limiting; however, 1 year after an initial episode, as many as 33% of people still have moderate-intensity pain and 15% have severe pain. Acute low back pain has a high recurrence rate; 75% of those with a first episode have a recurrence. Although acute episodes may resolve completely, they may increase in severity and duration over time.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments for acute low back pain? What are the effects of local injections for acute low back pain? What are the effects of non-drug treatments for acute low back pain? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 49 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, advice to stay active, analgesics (paracetamol, opioids), back exercises, back schools, bed rest, behavioural therapy, electromyographic biofeedback, epidural corticosteroid injections, lumbar supports, massage, multidisciplinary treatment programmes, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), spinal manipulation, temperature treatments (short-wave diathermy, ultrasound, ice, heat), traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Low back pain is pain, muscle tension, or stiffness, localised below the costal margin and above the inferior gluteal folds, with or without referred or radicular leg pain (sciatica), and is defined as acute when pain persists for <12 weeks. Low back pain affects about 70% of people in resource-rich countries at some point in their lives.Acute low back pain may be self-limiting, although there is a high recurrence rate with less-painful symptoms recurring in 50% to 80% of people within 1 year of the initial episode; 1 year later, as many as 33% of people still experience moderate-intensity pain and 15% experience severe pain.
NSAIDs have been shown to effectively improve symptoms compared with placebo. However, their use is associated with gastrointestinal adverse effects. Muscle relaxants may also reduce pain and improve overall clinical assessment, but are associated with some severe adverse effects including drowsiness, dizziness, and nausea.The studies examining the effects of analgesics such as paracetamol or opioids were generally too small to detect any clinically important differences.
We found no studies examining the effectiveness of epidural injections of corticosteroids in treating people with acute low back pain.
With regard to non-drug treatments, advice to stay active (be it as a single treatment or in combination with other interventions such as back schools, a graded activity programme, or behavioural counselling) may be effective. We don't know whether spinal manipulation improves pain or function compared with sham treatments.We found insufficient evidence to judge the effectiveness of acupuncture, back schools, behavioural therapy, massage, multidisciplinary treatment programmes (for either acute or subacute low back pain), lumbar supports, TENS, or temperature treatments in treating people with acute low back pain.We found no evidence examining the effectiveness of electromyographic biofeedback or traction in the treatment of acute low back pain. Back exercises may decrease recovery time compared with no treatment, but there is considerable heterogeneity among studies with regard to the definition of back exercise. There is a large disparity among studies in the definition of generic versus specific back exercise. Bed rest does not improve symptoms any more effectively than other treatments, but does produce a number of adverse effects including joint stiffness, muscle wasting, loss of bone mineral density, pressure sores, and venous thromboembolism.
PMCID: PMC3217769  PMID: 21549023
23.  Low back pain (chronic) 
Clinical Evidence  2010;2010:1116.
Introduction
Over 70% of people in developed countries develop low back pain (LBP) at some time. But recovery is not always favourable: 82% of non recent-onset patients still experience pain 1 year later. Many patients with chronic LBP who were initially told that their natural history was good spend months or years seeking relief.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral drug treatments? What are the effects of injection therapy? What are the effects of non-drug treatments? What are the effects of non-surgical and surgical treatments? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 64 systematic reviews or RCTs that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: acupuncture, analgesics, antidepressants, back schools, behavioural therapy, electromyographic biofeedback, exercise, injections (epidural corticosteroid injections, facet joint injections, local injections), intensive multidisciplinary treatment programmes, lumbar supports, massage, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), non-surgical interventional therapies (intradiscal electrothermal therapy, radiofrequency denervation), spinal manipulative therapy, surgery, traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Over 70% of people in developed countries develop low back pain at some time, which usually improves within 2 weeks, however about 10% remained off work and about 20% had persistent symptoms at 1 year.
Non-steroidal anti-inflammatory drugs (NSAIDs) may be more effective than placebo at improving pain intensity in people with chronic low back pain.
Opioid analgesics (with or without paracetamol) may improve pain and function compared with placebo. However, long-term use of NSAIDs or opioids may be associated with well-recognised adverse effects. We don't know whether antidepressants decrease chronic low back pain or improve function compared with placebo in people with or without depression. Benzodiazepines may improve pain, but studies of non-benzodiazepine muscle relaxants have given conflicting results.
CAUTION: Since the last update of this review, a drug safety alert has been issued on increased suicidal behaviour with antidepressants (www.fda.gov/medwatch).
We don't know whether epidural corticosteroid injections or local injections with corticosteroids and local anaesthetic improve chronic low back pain in people without sciatica. Facet-joint corticosteroid injections may be no more effective than placebo at reducing pain.
Fusion surgery is more effective than standard rehabilitation for improving pain in people with chronic non-radicular low back pain, but it is no better than intensive rehabilitation with a cognitive behavioural component.
Exercise improves pain and function compared with other conservative treatments.
Intensive multidisciplinary treatment programmes improve pain and function compared with usual care, but less-intensive programmes do not seem beneficial.
Acupuncture, back schools, behavioural therapy, and spinal manipulation may reduce pain in the short term, but effects on function are unclear.
Massage may improve pain and function compared with sham or other active treatment.
We don't know whether electromyographic biofeedback, lumbar supports, traction, or TENS improve pain relief.
We also don't know whether intradiscal electrothermal therapy, radiofrequency denervation, or disc replacement improve pain relief or function.
PMCID: PMC3217809  PMID: 21418678
24.  Management of Chronic Pain of Cervical Disc Herniation and Radiculitis with Fluoroscopic Cervical Interlaminar Epidural Injections 
Study Design: A randomized, double-blind, active controlled trial.
Objective: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis.
Summary of Background Data: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature.
Methods: One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone.
Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight.
Results: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group.
Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
doi:10.7150/ijms.4444
PMCID: PMC3410361  PMID: 22859902
Chronic neck pain; cervical disc herniation; upper extremity pain; cervical epidural injections; epidural steroids; local anesthetics
25.  Caudal epidural steroid injection: a randomized controlled trial 
Study design: Prospective study.
Study rationale: A recurrent phenomenon, the lifetime prevalence of low back pain has been reported as 54%–80%, while annual prevalence ranges from 15%–45%.1 It is also associated with enormous economic, societal, and health impact.2 India, being a developing country, has its problem compounded by the occupational compulsions in parts of the rural areas.3
For some interventional therapies, like epidural steroid injections, utilization rates have increased dramatically.4,5,6,7,8,9 They have become one of the most commonly performed interventions in the United States for low back pain with radiculopathy.10
Clinical question: Multiple systematic reviews,11 a meta-analysis,12 several guidelines,13 health technology assessments by insurers, and local medical review policies and coverage decisions have been published. However, controversy continues regarding the effectiveness of epidural steroid injections. In addition three types of epidurals, namely interlaminar, transforaminal, and caudal, with variable results complicate the picture for practice of interventional pain management. The underlying mechanism of action of epidurally administered steroid and local anesthetic injections is still not well understood and compounds the problem.14
Objective: To evaluate and update the effects of caudal epidural injection in the management of chronic low back pain and sciatica.
doi:10.1055/s-0031-1274753
PMCID: PMC3506149  PMID: 23230402

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